The efficacy and tolerability of alendronate in postmenopausal osteoporotic Chinese women: A randomized placebo-controlled study

Osteoporosis is a growing health problem in Asian women and it is expected that half of the world's hip fractures will occur in Asia in 50 years' time . As the use of hormonal replacement therapy (HRT) is extremely low in post menopausal Asian women, nonhormonal agents will be more acceptable for the treatment and prevention of osteoporosis. The efficacy, tolerability, and a cceptability of alendronate, an amino-bisphosphonate, for Asian women was e valuated in 70 osteoporotic southern Chinese women in a prospective, random ized, double-blind study. The subjects were randomized to receive either al endronate 10 mg daily or placebo, plus calcium supplementation 500 mg daily . The baseline L 1-4 and hip bone mineral density (BMD) were similar betwee n both groups. At the end of 1 year, there was an increase of 5.8% in the l umbar spine EMD and 3.4% at the total hip with alendronate treatment when c ompared with baseline values (P < 0.001). Alendronate treatment For I year resulted in significant improvement in BMD at all sites measured when compa red with placebo. There was also marked reduction in serum alkaline phospha tase (ALP) and urinary n-telopeptide (NTx) in the alendronate group when co mpared with the placebo group (ALP 25% versus 2%, NTx 75% versus 14%, both P < 0.005). The changes in ALP and NTx at 6 and 12 months correlated with t he change in BMD at all sites measured at 1 year (P all <0.05). Alendronate was well tolerated and accepted, although two cases of gastric ulcer were reported. We conclude that alendronate is an effective and well-accepted ag ent for the treatment of osteoporosis in Asian women.